Global Quality Lead

Jobinhalt

To strengthen our Global Products Quality Management team, we are looking for a talented individual to fill the position Global Quality Lead based in Braine l’Alleud, Belgium

You like to work in an environment where you will be:

• Owner of the Quality resources and capacity overview for project associated with the Product
• Support preparation and execution of product launches from QA perspective (e.g. launch strategy, align QA activities, submission review, attend launch team meetings, etc. ... )
• Ensure review and approve of CMC sections linked to regulatory original submissions, renewals or variations during any moment of the lifecycle management of the assigned product
• Be point of contact in Global Quality for regulatory inspections related to the assigned product, ensuring preparation in accordance with inspection readiness internal guidance and availability of key stakeholders for support during the inspections. Support post inspection observation closure.
• Review and approve Product Stability Strategy and Annual Stability Plan for accountable products
• Lead Product Change Control Committee
• QA stakeholder for Product Risk management
• Define and establish key performance indicators (metrics) for key product QA activities and services associated
• Represent the Global Quality Lead team or Global Quality Products Management when assigned to projects and initiatives where the GQL presence or product expertise is required.
• Lead Product Quality Complaints Committee
• Critical product quality defects which may lead to product recall

Interested? For this position you’ll need the following education, experience and skills:

• You have a minimum of 5-8 years working in the pharmaceutical/biologics industry in a quality management position. Operational experience in GMP in Quality, Manufacturing, or Quality Control would be a distinct advantage.
• You have a good knowledge and understanding of Good Manufacturing Practices Regulations and CMC Regulatory requirements.
• You have experience interacting with regulatory bodies with respect to QA systems and regulatory inspection readiness and follow up.
• GMP Auditing/Inspection expertise
• You Must have an advance level and competence in speaking, comprehension, and writing in English language which is the main day-to-day language required for this position.
• You must be knowledgeable in several areas of the global pharmaceutical industry, including the interpretation and practical application of applicable regulations. Has good background knowledge of the pharmaceutical industry from a business and technical perspective.

Why you should apply?

We can offer you an informal and open working environment that does not lock experts into structure and hierarchy. Freedom to take space to pursue your own ideas and make a difference. Opportunity to gain internal and external visibility through interactions with other UCB teams and with externals stakeholders. Opportunity to grow both as a recognized professional and leader through participation in project teams and our career/personal development programs.

At UCB, we strive to attract passionate and outstanding talents who thrive on change and are ready to bring real value to patients. Working for us you’ll discover a place where you can grow and express your full potential. We place an emphasis on innovation, collaboration and impact. Through meaningful recognition and a motivating work atmosphere, we aim to provide an optimal experience by caring about and valuing our employees – just as we do for the patients we serve.

If you believe you are the perfect match to join us on our pioneering adventure, then we invite you to apply and tell us more about your profile and motivation.